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Astellas receives EU approval for CDI treatment Dificlir
Astellas has been granted European regulatory approval for Dificlir, its new therapy for Clostridium difficile infections (CDI).
The European Commission has granted approval for the new therapy option based on its strong performance in two phase III clinical trials, during which it was able to prove its safety and efficacy.
CDI is a common problem in healthcare settings such as hospitals and nursing homes and is one of the most common causes of antibiotic-associated diarrhoea, with severe cases resulting in the need for surgery or even death.
Ken Jones, president and chief executive officer of Astellas Pharma Europe, noted that few advances have emerged in this field in the last 20 years, despite the impact it can have on quality of life.
"The EU approval of Dificlir, a novel macrocyclic antibiotic that specifically targets C difficile bacteria, is therefore an important advance for patients suffering from CDI," he added.
Last month, the company announced a new research alliance with the Riken Brain Science Institute, which will focus on the development of new treatments for Alzheimer's disease.
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